Last updated: August 1, 2026
HYPAQUE-M 75% is a legacy iodinated X-ray contrast product containing 75% w/v meglumine diatrizoate. Public evidence does not show an active clinical-development program, current product-specific revenue disclosure, meaningful patent protection, or a credible standalone market forecast. Its commercial position is limited by generic availability, replacement by newer low-osmolar contrast media, and the likely discontinued or inactive status of the original branded product.
What is HYPAQUE-M 75%?
HYPAQUE-M 75% is an injectable radiopaque diagnostic agent used to enhance visualization during radiographic procedures. Its active ingredient is meglumine diatrizoate, an ionic, high-osmolar iodinated contrast medium.
| Attribute |
HYPAQUE-M 75% |
| Active ingredient |
Meglumine diatrizoate |
| Concentration |
75% w/v |
| Therapeutic category |
Iodinated X-ray contrast agent |
| Drug type |
Small-molecule diagnostic agent |
| Administration |
Injection |
| Primary use |
Radiographic contrast enhancement |
| FDA pathway |
Legacy prescription drug product |
| Biological product |
No |
| Biosimilar pathway |
Not applicable |
| Current clinical-development status |
No active product-specific development program identified |
| Patent position |
Core composition and use protection expired |
| Main competitors |
Generic diatrizoate products and modern low-osmolar contrast agents |
The product belongs to an older generation of ionic contrast media. Current clinical practice relies more heavily on low-osmolar or iso-osmolar agents because they generally provide improved tolerability and broader procedural utility compared with high-osmolar products.
What clinical trials involve HYPAQUE-M 75%?
No active interventional clinical-trial program specifically evaluating HYPAQUE-M 75% 75% is identified in the public ClinicalTrials.gov record. The product is not positioned as an investigational therapy, and new trials would be commercially difficult to justify for an established diagnostic agent with extensive historical clinical use.
Historical studies involving diatrizoate products generally addressed:
- Diagnostic performance in radiography and angiography
- Adverse reactions to ionic iodinated contrast media
- Renal and cardiovascular tolerability
- Comparison with other contrast agents
- Administration techniques and imaging quality
These historical studies do not constitute a current HYPAQUE-M 75% development program. The relevant regulatory question is product availability and labeling, not clinical efficacy development.
Is HYPAQUE-M 75% approved by the FDA?
HYPAQUE products were marketed as FDA-regulated iodinated contrast agents. The product’s original regulatory status should be distinguished from current commercial availability. FDA records can list a drug as discontinued without determining that the product was withdrawn for safety or effectiveness reasons.
The FDA labeling framework for diatrizoate products identifies risks associated with iodinated contrast administration, including hypersensitivity reactions, renal impairment, cardiovascular effects, extravasation, and thyroid-related effects. Current prescribing decisions must rely on the applicable product label and institutional contrast-media protocols. [1]
Why are there no meaningful new HYPAQUE-M 75% trials?
The product has limited development potential because:
- Meglumine diatrizoate has been used clinically for decades.
- The active ingredient is off-patent.
- Clinical differentiation from generic diatrizoate is limited.
- Low-osmolar agents have displaced many legacy ionic contrast products.
- A new trial would not create meaningful regulatory exclusivity for the active ingredient.
Clinical-trial activity in the broader contrast-media field is more likely to involve imaging agents, targeted molecular imaging, artificial intelligence, or new delivery systems than a legacy diatrizoate formulation.
When does HYPAQUE-M 75% lose patent exclusivity?
Core patent exclusivity for meglumine diatrizoate and the HYPAQUE formulation has expired. No commercially meaningful active-ingredient patent barrier is expected to prevent generic competition.
| Protection category |
Current assessment |
| Active ingredient patents |
Expired |
| Original formulation patents |
Expired |
| Method-of-use patents |
Historical protection expired or commercially immaterial |
| Manufacturing patents |
Any surviving rights would not protect the core marketed product |
| Pediatric exclusivity |
Not commercially relevant |
| Orphan exclusivity |
Not applicable |
| Biologic exclusivity |
Not applicable |
| Data exclusivity |
Expired or not relevant to current generic supply |
A manufacturer could still seek protection for a new formulation, container, concentration, manufacturing process, or delivery system. Such rights would not restore exclusivity to the original HYPAQUE-M 75% product unless they covered a commercially necessary product feature.
What is the Orange Book status of HYPAQUE-M 75%?
The Orange Book status of a legacy HYPAQUE product depends on the specific National Drug Code, sponsor, and FDA application record. The brand should not be treated as an actively protected reference product solely because historical NDA or label records remain accessible.
The relevant Orange Book and FDA questions are:
- Whether the original NDA remains listed.
- Whether the product is identified as discontinued.
- Whether an approved abbreviated new drug application references the product.
- Whether any patent or exclusivity information remains listed.
- Whether the product has been withdrawn from sale for commercial reasons or for safety or effectiveness reasons.
For a discontinued legacy contrast product, Orange Book listings generally have limited strategic value unless a currently marketed generic relies on the original reference-drug approval for approval status. [2]
How strong is the patent estate for HYPAQUE-M 75%?
The patent estate is weak from a commercial-exclusivity perspective.
Composition and formulation protection
The composition of meglumine diatrizoate is old and available to generic manufacturers. The 75% concentration is also a mature formulation characteristic rather than a novel product feature.
Method-of-use protection
Historical diagnostic uses do not provide durable market exclusivity. Broad method-of-use claims for radiographic contrast enhancement would face substantial validity and prior-art challenges.
Manufacturing and supply-chain protection
Manufacturing know-how can affect product quality, sterility, impurity control, and regulatory compliance. It does not create a meaningful legal barrier when qualified manufacturers can produce the same active ingredient and dosage form.
The strongest practical barriers are therefore regulatory and operational:
- Sterile injectable manufacturing capacity
- Validated filling and packaging
- Iodinated contrast supply
- FDA quality requirements
- Hospital formulary qualification
- Pharmacovigilance and adverse-event monitoring
These barriers can constrain supply but do not support premium pricing comparable to a patented drug.
Which companies compete with HYPAQUE-M 75%?
HYPAQUE-M 75% competes with two distinct groups.
Generic diatrizoate suppliers
Generic manufacturers may supply diatrizoate meglumine or related diatrizoate formulations, subject to FDA approval and commercial availability. Supplier participation can change as manufacturers enter or exit the sterile injectable market.
Modern iodinated contrast manufacturers
The more important competitive threat comes from companies marketing low-osmolar and iso-osmolar contrast agents, including:
| Company |
Representative contrast products |
Competitive position |
| GE HealthCare |
Omnipaque, Visipaque |
Broad hospital and imaging-center use |
| Bayer |
Ultravist |
Low-osmolar diagnostic contrast |
| Bracco |
Isovue |
Broad radiology use |
| Guerbet |
Xenetix and other contrast products in selected markets |
International contrast portfolio |
| Generic manufacturers |
Generic iohexol, iopamidol, ioversol, diatrizoate |
Price competition and supply substitution |
The precise competitive set varies by country, procedure, formulary, and product availability.
What is the market outlook for HYPAQUE-M 75%?
The product-specific market outlook is declining to negligible. Public companies generally do not report HYPAQUE-M 75% revenue separately, and no reliable public forecast isolates its sales.
| Market factor |
Effect on HYPAQUE-M 75% |
| Generic competition |
Strong negative |
| Low-osmolar substitution |
Strong negative |
| Patent expiry |
Eliminates exclusivity |
| Hospital price controls |
Negative |
| Diagnostic imaging volume |
Potentially supportive for the category |
| Product discontinuation risk |
Strong negative |
| Clinical differentiation |
Limited |
| Manufacturing complexity |
Creates supply risk but not pricing power |
The broader iodinated contrast-media market can continue to grow with imaging volumes, CT utilization, angiography, and hospital procedure demand. That category growth should not be used as a proxy for HYPAQUE-M 75% growth. Most incremental value is likely to accrue to currently marketed low-osmolar products, supply-secure generics, and differentiated imaging agents.
Three-year commercial projection
| Period |
HYPAQUE-M 75% outlook |
Market interpretation |
| 2025 |
Legacy or limited availability |
No product-specific growth driver |
| 2026 |
Flat to declining |
Further substitution and supply rationalization |
| 2027 |
Niche or absent commercial role |
Generic and modern-agent displacement |
This is a directional projection rather than a revenue forecast because public product-level sales data are not available. A numerical forecast would imply a degree of market visibility that the product does not have.
What generic entry risks exist for HYPAQUE-M 75%?
Generic entry risk is high because the active ingredient and dosage form are mature. The principal risk is not a future Paragraph IV event against an unexpired patent. It is direct substitution by existing generic or alternative contrast products.
Paragraph IV challenges
A Paragraph IV challenge is unlikely to be commercially significant for the original HYPAQUE-M 75% product because:
- Core patents have expired.
- The branded product has limited current commercial value.
- Generic competition can proceed without attacking a meaningful remaining patent estate.
- Competitors can target related diatrizoate products or other contrast agents.
If a current sponsor obtained approval for a genuinely novel HYPAQUE-derived formulation, that formulation could create a new patent dispute. That scenario would concern the new product, not the historical 75% formulation.
Generic launch scenarios
| Scenario |
Probability assessment |
Commercial effect |
| Continued limited legacy supply |
Possible |
Maintains niche use where formulary-specific |
| Generic diatrizoate substitution |
High |
Reduces brand relevance |
| Replacement by low-osmolar agents |
High |
Reduces procedure volume |
| New branded HYPAQUE formulation |
Low |
Requires meaningful clinical or operational differentiation |
| Complete commercial withdrawal |
Possible to likely |
Leaves the product with historical rather than active-market value |
What patent litigation or settlements affect HYPAQUE-M 75%?
No material current patent litigation or settlement involving the historical HYPAQUE-M 75% product is identified in the publicly available regulatory and clinical-trial record. The product’s age and lack of meaningful remaining composition or formulation exclusivity reduce the probability of a current branded-generic patent dispute.
Litigation risk is more likely to arise from:
- Manufacturing quality disputes
- Product-liability claims
- Contrast-agent adverse events
- Supply agreements
- Regulatory inspections
- Generic approval disputes involving a different diatrizoate product
These issues should not be confused with active patent litigation over HYPAQUE-M 75%.
What licensing deals involve HYPAQUE-M 75%?
No current material licensing transaction centered on HYPAQUE-M 75% is identified in public sources. Historical brand ownership and distribution arrangements may have changed as contrast-media portfolios moved among pharmaceutical and diagnostic-imaging companies, but those arrangements do not establish current commercial momentum.
A license involving the legacy product would likely concern:
- Geographic distribution
- Manufacturing rights
- Product registration transfer
- Hospital supply
- Portfolio rationalization
It would not ordinarily create new exclusivity for meglumine diatrizoate.
How does HYPAQUE-M 75% compare with modern contrast agents?
| Attribute |
HYPAQUE-M 75% |
Modern low-osmolar agents |
| Osmolality |
High |
Lower |
| Active ingredient maturity |
Very old |
Established, but newer commercial positioning |
| Patent protection |
Expired |
Product-specific protection varies |
| Generic competition |
High |
Increasing |
| Tolerability profile |
Less favorable in many settings |
Generally preferred |
| Clinical differentiation |
Limited |
Better aligned with current imaging practice |
| Commercial trajectory |
Declining or niche |
Larger active market |
| Biosimilar exposure |
None |
None, because these are small molecules |
| Main investment thesis |
Supply continuity or niche demand |
Imaging-volume growth and manufacturing scale |
HYPAQUE-M 75% may remain relevant where clinicians, facilities, or regulators maintain legacy protocols. Its clinical role is narrower than that of contemporary low-osmolar contrast products.
Key Takeaways
- HYPAQUE-M 75% contains 75% w/v meglumine diatrizoate, an ionic high-osmolar iodinated contrast agent.
- No active product-specific clinical-trial program is identified.
- Core composition, formulation, and use protection have expired.
- No meaningful biosimilar issue applies because the product is a small-molecule diagnostic agent.
- Generic entry and substitution risk are high.
- Low-osmolar contrast agents are the principal commercial competitors.
- No material current patent litigation, Paragraph IV campaign, or licensing transaction is identified.
- Product-specific revenue and market forecasts are not publicly disclosed.
- The commercial outlook is flat to declining, with potential continuation only in limited legacy or supply-constrained settings.
- Broader iodinated contrast-market growth should not be treated as HYPAQUE-M 75% growth.
FAQs
Is HYPAQUE-M 75% the same as Gastrografin?
No. Both are associated with diatrizoate chemistry, but product composition, concentration, route of administration, labeling, and clinical indications differ. Gastrografin is an oral or enteral contrast formulation containing diatrizoate salts and is not interchangeable with an injectable HYPAQUE-M 75% product.
Does HYPAQUE-M 75% have biosimilar competition?
No. Biosimilars apply to biological products. HYPAQUE-M 75% is a small-molecule iodinated contrast agent and faces generic-drug and therapeutic-substitution competition instead.
Can a new company obtain patents on meglumine diatrizoate?
A company could seek patents covering a genuinely novel formulation, device, manufacturing process, or delivery method. It cannot obtain a valid broad monopoly over the old active ingredient merely by seeking a new patent.
Is HYPAQUE-M 75% still used for CT scans?
Use depends on local product availability, labeling, institutional protocols, and clinician preference. Modern CT practice generally favors low-osmolar iodinated contrast agents, although legacy diatrizoate products may remain in selected settings.
What is the principal investment risk for HYPAQUE-M 75%?
The principal risk is commercial obsolescence rather than patent expiration. Generic substitution, product discontinuation, sterile-injectable supply constraints, and replacement by low-osmolar agents limit the value of the historical brand.
References
-
U.S. Food and Drug Administration. (n.d.). Diatrizoate meglumine injection prescribing information. FDA labeling database.
-
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
-
U.S. National Library of Medicine. (n.d.). DailyMed: Diatrizoate meglumine injection product information. DailyMed.
-
U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov search results for HYPAQUE-M and meglumine diatrizoate. ClinicalTrials.gov.
-
U.S. Food and Drug Administration. (n.d.). Drug discontinuation and product-status information. FDA Drug Database.
